N/A
N=11,197
Clinical Decision Support for Opioid Use Disorders in Medical Settings (COMPUTE 2.0)
Opioid-use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT04198428 ↗Enrolled (actual)
11,197
Serious AEs
66.9%
Results posted
Oct 2025
Primary outcome: Primary: Number of Patients With OUD Diagnosis — 36; 24 participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Opioid Wizard (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- HealthPartners Institute
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Patients With OUD Diagnosis |
36; 24 | <0.05 sig |
| PRIMARY Number of Patients With Naloxone Rescue Kit Order |
80; 40 | <0.05 sig |
| PRIMARY Number of Patients With a MOUD Order or Referral |
785; 517 | <0.05 sig |
| PRIMARY Days Covered by MOUD Prescription |
84; 83 | <0.05 sig |
| SECONDARY Emergency Department Visits Per Patient-year |
1.30; 1.37; 1.06; 1.12 | <0.05 sig |
| SECONDARY Hospitalizations Per Patient-year |
0.40; 0.40; 0.32; 0.33 | <0.05 sig |
| SECONDARY Healthcare Costs |
-1971; -903 | <0.05 sig |
| SECONDARY All-cause Mortality Per 100 Patient-years. |
2.79; 2.64 | <0.05 sig |
| SECONDARY Overdoses Per 100 Patient-years. |
4.51; 5.32; 3.13; 3.42 | <0.05 sig |
Summary
Through CTN-0076-Ot (Clinical Decision Support for Opioid Use Disorders in Medical Settings: Pilot Usability Testing in an EMR (COMPUTE)), our team has iteratively developed and piloted a web-based and electronic health record (EHR)-integrated Opioid Use Disorder (OUD) Clinical Decision Support (CDS) system to offer expert guidance to primary care providers (PCPs) on the diagnosis and management of OUD. The OUD-CDS has been implemented within the EPIC EHR of one large care system and was piloted with 55 providers to ensure content validity and provider satisfaction. The team will now implement this OUD-CDS in a large multi-site clinic-randomized controlled trial to evaluate its impact on practice process measures and patient outcomes. The investigators also aim to prepare for scalability (i.e., integration into usual primary care practice after the study is complete) and dissemination by evaluating facilitators and barriers to implementation, determining the costs of implementation and maintenance, and assessing the short-term cost impacts of the OUD-CDS.
The study will include three large diverse care systems and randomize a minimum of 30 clinics to receive the OUD-CDS intervention or usual care (UC). In intervention clinics, the OUD-CDS will identify patients who are at high risk for OUD or diagnosed with OUD; use data stored in the EHR for each eligible patient to assemble treatment recommendations tailored to each patient's current needs; display these recommendations to PCPs via the OUD-CDS user interface; and store analytic data from all targeted visits. In UC clinics, the OUD-CDS will run invisibly in the background to identify high-risk or OUD patients, assemble treatment recommendations tailored to each eligible patient's needs, and store analytic data from all targeted visits.
Eligibility Criteria
Inclusion Criteria
- be aged 18-75 years, inclusive, at the time of an index visit;
- have been diagnosed with OUD, currently prescribed MOUD, or identified by study algorithms as being at high risk of OUD.
- Be a patient at a study randomized clinic
Exclusion Criteria
- those receiving active parenteral chemotherapy within the last year,
- those with stage 4 or equivalent cancer diagnosis
- those enrolled in hospice care or palliative care programs.
Data sourced from ClinicalTrials.gov (NCT04198428). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.